Time to Update Your Corporate Bylaws?
New York Gov. Andrew Cuomo signed the New York Non-Profit Revitalization Act of 2013 (Act), into law in December 2013, thereby adopting important changes to the governance of...more
On November 7, 2013, the Food and Drug Administration (FDA) announced that it has tentatively determined that partially hydrogenated oils (PHOs) are no longer generally recognized as safe (GRAS) for any use in food. PHOs are...more
Last week, The U.S. Food and Drug Administration (the “FDA”) issued long-awaited final guidance for the mobile medical applications (“Apps”) industry and FDA staff (the “Guidance”). The Guidance notes that it contains...more
In Federal Trade Commission v. Actavis, Inc., No. 12-416, 2013 U.S. LEXIS 4545 (U.S. June 17, 2013), the U.S. Supreme Court reversed the Eleventh Circuit decision in FTC v. Watson Pharmaceuticals, Inc., 677 F.3d 1298 (2012),...more
In a resounding manner, members of the medical device industry recently filed comments reacting to the Food and Drug Administration’s proposed rule to strengthen its oversight of overseas clinical studies of medical devices....more
In a remarkable move, the Food and Drug Administration recently indicated that it plans to take new steps to regulate laboratory-developed tests (“LDTs”). FDA Commissioner Margaret Hamburg made the significant announcement...more